Trial of Alvimopan in Major Spine Surgery
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|ClinicalTrials.gov Identifier: NCT02789111|
Recruitment Status : Unknown
Verified May 2018 by Bhiken I. Naik, MD, University of Virginia.
Recruitment status was: Recruiting
First Posted : June 2, 2016
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: Alvimopan Drug: Placebo||Phase 4|
Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects. Such side effects may include urinary retention, altered mental status, depressed respiratory drive, and constipation, and may lead to reduced nutritional intake in the postoperative period. Importantly, post-operative nutrition may impact the incidence of complications following spine surgery.1 Alvimopan is a peripheral-acting opiate antagonist designed to decrease the gastrointestinal complications of perioperative systemic opioid administration.
Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects including constipation. Alvimopan is a drug approved by the Food and Drug Administration (FDA) and is used to help the bowel recover more quickly in patients who are having bowel surgery, so that they can eat solid foods and have regular bowel movements. Alvimopan is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the constipation effects of opioid (narcotic) medications that are used to treat pain after surgery.
The purpose of this study is to determine if the use of alvimopan in major spine surgery reduces the time to first bowel movement. By assessing the use of alvimopan in reconstructive spinal surgery patients, researchers hope to give the scientific community insight into the broader use of this drug in other surgical populations, as well as gathering information on the impact of hospital charges and overall post-operative patient satisfaction.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Trial of Alvimopan in Major Spine Surgery|
|Actual Study Start Date :||June 1, 2016|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
Active Comparator: Alvimopan
12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.
Alviimopan 12 mg twice daily up to 15 doses
Other Name: Entereg
Placebo Comparator: Placebo
Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.
Placebo twice daily up to 15 doses
- time to first bowel movement [ Time Frame: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement ]time to first bowel movement
- time to resumption of PO intake [ Time Frame: time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake ]time to resumption of PO intake
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789111
|Contact: Marcia E Birk, RNemail@example.com|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Marcia E Birk, RN 434-924-2283 firstname.lastname@example.org|
|Contact: Bhiken Naik, MBBCh 434-924-2283 email@example.com|
|Principal Investigator: Bhiken Naik, MBBCh|
|Principal Investigator:||Bhiken Naik, MBBCh||Anesthesiology Attending|